Skip to Content

Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: July 23, 2018

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Salmonella Spurs Recall of Swiss Rolls Possible salmonella contamination has led to the recall of rolls and bread made by Flowers Foods, Inc. The recall includes Swiss Rolls distributed across the United States and sold under the brand names Mrs. Freshley's, Food Lion, H-E-B, Baker's Treat, Market Square, and... Read more

Many Struggle With High Cost of Breast Cancer Care

Posted today in Medical

MONDAY, July 23, 2018 -- The cost of treatment for early stage breast cancer can be devastating for many patients, but they get little guidance or help from their doctors, a new study suggests. "We have made a lot of progress in breast cancer treatment, which is wonderful. But this study shows we are only part of the way to our goal. We must now turn our efforts to confronting the financial devastation many patients... Read more

Why Alzheimer's May Be Tougher to Spot in Women

Posted today in Medical

MONDAY, July 23, 2018 -- If your memory starts slipping, your gender may play a role in whether or not you are diagnosed with Alzheimer's disease, a new study suggests. How? Women excel in a skill called verbal memory -- the ability to learn and remember verbal information such as stories or grocery lists. At the moment, tests to detect Alzheimer's disease rely heavily on measuring this skill, the study authors... Read more

Large U.S. Study Targets Prostate Cancer in Black Men

Posted today in Medical

MONDAY, July 23, 2018 -- Black men in the United States have higher rates of aggressive prostate cancer than other males. Now, a $26.5 million study is underway to figure out why. The U.S. National Institutes of Health and the Prostate Cancer Foundation have launched the study to investigate social, environmental and genetic factors behind this disparity. "No group in the world is hit harder by prostate cancer than... Read more

Gluten-Free Kids' Foods Fall Short on Nutrition

Posted today in Medical

MONDAY, July 23, 2018 -- Gluten-free foods are one of the latest nutritional trends, with many parents assuming foods with a gluten-free label are healthier than foods with gluten. But new research says that's just not true, unless your child truly must avoid gluten -- a protein found in wheat, barley and rye -- due to celiac disease or other conditions. Almost 9 out of 10 gluten-free foods aimed at children could... Read more

FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria

Posted 2 days ago in New Drug Approvals

London UK; Philadelphia US; Geneva, Switzerland - July 20, 2018 -- GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate... Read more

FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen

Posted 2 days ago in New Drug Approvals

July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. “The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have c... Read more

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

Posted 2 days ago in New Drug Approvals

July 20, 2018 -- The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with... Read more

Greening Vacant Land Improves Neighborhood Mental Health

Posted 2 days ago in News for Health Professionals

FRIDAY, July 20, 2018 -- Fixing up blighted physical environments, particularly in resource-limited urban settings, may improve the mental health of residents living nearby, according to a study published in the July issue of JAMA Network Open. Eugenia C. South, M.D., from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues evaluated whether interventions to green vacant... Read more

Unfavorable Prepregnancy Lipid Levels Linked to Low Parity

Posted 2 days ago in News for Health Professionals

FRIDAY, July 20, 2018 -- The risk of having no or only one child is elevated for women with an unfavorable prepregnancy lipid profile, according to a study published in the June issue of BMJ Open. Aleksandra Pirnat, from the University of Bergen in Norway, and colleagues conducted a prospective, population-based cohort study using data for 2,645 women giving birth to their first child during 1994 to 2003 (488... Read more

C.S. Mott Poll Addresses Child Safety at Amusement Parks

Posted 2 days ago in News for Health Professionals

FRIDAY, July 20, 2018 -- One in five parents say they have not made plans with their children about what to do if they became separated at an amusement park or carnival, according to the C.S. Mott Children's Hospital National Poll on Children's Health at the University of Michigan. In a survey that included more than 1,200 parents of children aged 5 to 12, the poll authors also asked parents what they would do if... Read more

Increased Coverage in States With Medicaid Expansion

Posted 2 days ago in News for Health Professionals

FRIDAY, July 20, 2018 -- Coverage rates and access to care are significantly higher in states with Medicaid expansion, compared with non-expansion states, according to a study published in the July issue of Health Affairs. Benjamin D. Sommers, M.D., Ph.D., from the Harvard T.H. Chan School of Public Health in Boston, and colleagues used a novel telephone survey to examine views on health savings accounts, work... Read more

Bayer Stops U.S. Sale of Essure Birth Control Implant

Posted 2 days ago in News for Health Professionals

FRIDAY, July 20, 2018 -- Amid lawsuits and plummeting sales for its Essure birth control device, Bayer announced Friday that it would cease U.S. sales of the product by the end of 2018. The announcement comes after years of claims by thousands of American women who used the implant that Essure caused serious problems. Those problems include chronic pain and perforations of the uterus and fallopian tubes. Bayer... Read more

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

Posted 5 days ago in New Drug Approvals

TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide - D/C/F/TAF), the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and ce... Read more

FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox

Posted 9 days ago in New Drug Approvals

July 13, 2018 -- The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. “To address the risk of bioterrorism, Congress has t... Read more

Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA

Posted 10 days ago in New Drug Applications

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Evenity™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Evenity increases bone f... Read more

FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria

Posted 11 days ago in New Drug Applications

London UK; Philadelphia US; Geneva, Switzerland - 12 July 2018 - GSK and Medicines for Malaria Venture (MMV) today announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical... Read more

FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia

Posted 3 weeks ago in New Drug Applications

June 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of ... Read more

Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER

Posted 3 weeks ago in New Drug Applications

AUSTIN, Texas, June 26, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 14 to 3 against the approval of Remoxy ER (oxycodone extended-release capsules) for the... Read more

Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.

Posted 4 weeks ago in New Drug Applications

NEW HAVEN, Conn.--(BUSINESS WIRE) June 19, 2018 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The submission uses a rare disease p... Read more

Catalyst Biosciences Announces Positive Interim Data from a Phase 2/3 Study of Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors

Posted 4 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., July 18, 2018 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced interim data from its Phase 2/3 study of subcutaneous (SQ) prophylactic Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) being developed for the treatment of... Read more

Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain

Posted 4 days ago in Clinical Trials

July 18, 2018 - Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a... Read more

Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy Fidanacogene Elaparvovec

Posted 6 days ago in Clinical Trials

July 16, 2018 -- Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for... Read more

Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation Insight

Posted 10 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE) July 12, 2018 --Vaxart, Inc. (Nasdaq:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation... Read more

BioSight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia

Posted 12 days ago in Clinical Trials

AIRPORT CITY, Israel, July 11, 2018 /PRNewswire/ -- BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, announced today that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML). The trial, which will be launched in the upcoming month, will be... Read more